On August 15, 2023, the U.S. Food and Drug Administration (“FDA”) released final guidance on informed consent for clinical investigations (“Final Guidance”). This update follows FDA’s draft guidance, which was issued in July 2014, and supersedes the FDA’s “A Guide to Informed Consent,” which was issued in September 1998. The Final Guidance is intended to assist clinical research stakeholders, such as institutional review boards (“IRBs”), investigators, and sponsors, in complying with FDA’s informed consent regulations for clinical ...
In this episode of the Diagnosing Health Care Podcast: While the COVID-19 pandemic seems to be moving into our rearview mirror, government investigations and enforcement actions targeting COVID-19-related fraud are just starting to heat up.
What can businesses do to prevent or mitigate potential civil and criminal charges in this area?
In this episode of the Diagnosing Health Care Podcast: What has contributed to the biotechnology industry’s explosive growth over the last several years? In this episode, special guests Don and Lisa Drakeman, two former CEOs of biotech companies, reflect on what it takes to succeed, the regulatory challenges they have faced, and how current events are shaping the future of the industry.
Recent Updates
- CMS Receives Its Exclusion Authority: What Happens Now?
- GLOBE Model Final Rule Drops — but Will It Work on a Smaller Scale?
- Congressional Action on Health Care Cybersecurity: HISAA Is Re-Introduced and the Health Care Cybersecurity and Resiliency Act Moves Forward
- DOJ Corporate Fraud Enforcement Memo: What Health Care Companies Need to Know Now
- Attorneys General of Three States File Two Sweeping Lawsuits Targeting Telehealth Abortion Providers and State Shield Laws